How has the campus continuing review policy been revised?
The campus continuing review policy has been revised to allow the IRB to determine that studies meeting specific criteria no longer require continuing review. Please see the continuing review policy for the specific criteria a study must meet to qualify for no further continuing reviews.
Why is this change being made?
This change to the continuing review policy is being made for two primary reasons:
• To leverage flexibility in the existing federal regulations in order to reduce administrative burden for study teams and IRB alike.
• To begin preparing for pending changes to federal regulations which will allow some studies to be exempt from the requirement to submit a continuing review.
When will the ED/SBS begin implementing the revised policy?
The IRB will begin implementing the revised policy October 2nd 2017, which is the first business day following updates to the ARROW system that are required to implement the revised policy.
How will the revised policy be implemented for new studies?
Many application submitted to the ED/SBS IRB that will qualify for exception from the continuing review policy. As a result, all applications for new studies submitted to our office on or after October 2nd 2017 will be assessed to determine whether they qualify for exception from continuing review.
How will the revised policy be implemented for studies already approved by the IRB?
Studies currently approved by the IRB will be assessed at the next continuing review to determine whether they qualify for an exception to ongoing continuing review. The IRB needs to determine on a study-by-study basis whether the criteria of the revised policy are met and this most efficient way to accomplish this. This same process will be used for assessing the impact of the revised Common Rule on currently approved studies starting in January 2018.
How will study teams be notified that their study does not require continuing review?
The continuing review status for each study will be communicated to study teams via the approval letter for a new application or, for ongoing studies, a continuing review. A new study status will be added to ARROW – called Approved with No CR – to also provide a clear indication of whether continuing review is required for each study.
If ongoing continuing review is not required for my study, do I still need to submit changes or reportable events?
Yes. Studies not requiring continuing review must continue to submit through ARROW the following to the IRB for review and approval:
• Changes of protocol, including personnel changes
• Funding updates
• Reportable events
• Closure reports
Can the continuing review requirements for my study change?
Yes. Studies that have been determined to not require ongoing continuing review may no longer qualify for this exception in certain situations, such as:
• Addition of federal funding (until the revised Common Rule becomes effective in January 2018)
• Enrollment of prisoners
If a study no longer qualifies for an exception to continuing review, the study team will be notified during the approval process for the change that resulted in a switch in continuing review status.
If the IRB has determined my study no longer requires ongoing continuing review, does the campus Five Year Replacement/Renewal policy still apply?
No, the Five Year Renewal policy does not apply to studies the IRB determines do not require ongoing continuing review. When studies that do not require continuing review have been open for five years, the study team will receive an automatic reminder from ARROW. This reminder will request that the study team either complete a two question “Renew Approval” activity to indicate the study is ongoing or submit a study closure report if the study is not ongoing.
Please note that should the continuing review status for a study change, the study may then fall under the Five Year Renewal policy and a replacement application may be required.
How will revisions to the Common Rule impact the campus continuing review policy?
Revisions to the Common Rule are slated to go into effect January 19, 2018. The revisions include a provision that will no longer require continuing review for studies and:
• Qualify for expedited review or limited IRB review; or
• Have progressed to the data analysis stage or long-term follow-up limited to collecting data from procedures that subjects would undergo as part of clinical care.
THE SAME PROCESSES DESCRIBED ABOVE WILL BE USED TO IMPLEMENT THE NEW CONTINUING REVIEW EXCEPTION. THE ED/SBS IRB WILL BE SURE TO KEEP RESEARCHERS UP TO DATE WITH INFORMATION ON HOW THESE AND OTHER REVISIONS TO THE COMMON RULE WILL BE IMPLEMENTED.